Polybutene containing denture cleanser compositions

ABSTRACT

A denture cleanser composition comprising polybutene, with a molecular weight of about 300 to about 3000, an effervescence generator and a bleaching agent. Optionally, denture cleanser compositions may further comprise tablet binders, organic peroxyacid bleach precursors, surfactants including a dimethicone copolyol, lipophilic compounds such as flavorants and coolants, chelating agents, and other therapeutic and cosmetic active agents.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. Ser. No. 10/084,870,filed Feb. 28, 2002 which claims the benefit of U.S. ProvisionalApplication No. 60/276,976, filed Mar. 19, 2001.

FIELD OF THE INVENTION

[0002] The present invention relates to a cleanser composition that isespecially useful for cleansing dentures and the like. In particular,the present invention relates to denture cleansing compositions havingenhanced anti-plaque activity together with excellent denture cleansingperformance, which may be used to deliver additional therapeutic andcosmetic benefits.

BACKGROUND OF THE INVENTION

[0003] Effervescent tablets and powders for cleansing dentures are wellknown in the art. The aim of a denture cleanser product is to clean thedenture as fully and as quickly as possible to remove the accumulationof plaque, mucilaginous and bacterial deposits which collect while thedenture is being worn. To wear a denture, which has not been completelycleaned of plaque and bacterial deposits, is not only unhygienic but canalso, within a short time, result in detrimental effects to the mucousmembrane. Moreover, bacterial deposits can lead to so-called bacterialcorrosion of the plastics material used to produce the denture withconsequent color change and malodor formation. Conventional denturecleansers typically do not maintain actives in the oral cavity longenough to optimally enhance or prolong the therapeutic, prophylacticand/or cosmetic benefits provided by the actives. In order to provide adenture cleanser with sufficient substantivity to provide sustainedrelease of a denture cleansing agent and optionally additional denturecare actives, the use of polybutene in a denture cleanser composition isherein disclosed.

[0004] Polybutene is recognized as a component of denture adhesives andas a gum base. U.S. Pat. No. 5,880,172, issued Mar. 3, 1999, to Rajaiah,et al., discloses a self-supporting denture adhesive that is peelablefor easy removal, which incorporates polybutene as an optionalingredient. U.S. Pat. No. 5,496,541, issued Mar. 5, 1996, to Cutler,relates to a dentifrice chewing gum and teaches the use of polybutene asan optional gum base. Such known applications often employ a highermolecular weight polybutene in order to achieve the desired results.

[0005] In the present invention lower molecular weight polybutene isincorporated in the denture cleanser composition to provide a protectivecoating on the artificial teeth. The lower molecular weight polybuteneis a flowable liquid that achieves good coating of the denture and isextremely substantive. Sustained release of the denture cleansing activeagent is achieved. Through sustained release of additional denture careactives optionally incorporated in the present invention the denturesurface receives optimal therapeutic and cosmetic benefits.

[0006] The present invention provides a denture cleanser compositionthat effectively cleanses dentures, dental plates, and other hardsurfaces temporarily fixed within the oral cavity and provides a coatingto the same surfaces thereby preventing the buildup of plaque and otherdebris. The coating inhibits and prevents staining of the denture. Thiscoating also provides a slick, smooth feel to the denture surface, whichconsumers view as an indicator of clean teeth. The coating may alsoprovide sustained release of other denture care actives and ingredients.

SUMMARY OF THE INVENTION

[0007] The present invention relates to a denture cleanser compositioncomprising polybutene with a molecular weight of about 300 to about3000; an inorganic persalt bleaching agent; and an effervescencegenerator. Additional components may be added to the present inventionincluding, without limitation, an organic peroxyacid bleach precursor,lipophilic compounds, dental abrasives, binders, humectants,surfactants, chelating agents and other denture care actives.

DETAILED DESCRIPTION OF THE INVENTION

[0008] The denture cleanser compositions of the invention comprisepolybutene, an effervescence generator and an inorganic persaltbleaching agent. In one embodiment, these essential components aresupplemented by additional components, which may include an organicperoxyacid bleach precursor, lipophilic compounds, dental abrasives,binders, humectants, surfactants, chelating agents, and other cosmeticand therapeutic denture care actives. Each of these will be discussed inturn.

[0009] Definitions

[0010] The terms “artificial teeth” and “dentures”, as used herein, aremeant to include dentures, dental plates, bridges and other hardsurfaces of dental appliances which are temporarily fixed within theoral cavity and which are typically removed from the oral cavity forcleaning.

[0011] By “safe and effective amount”, as used herein, is meant anamount of an agent (e.g., anti-calculus agent) high enough tosignificantly improve the condition to be treated, but low enough toavoid serious side effects (at a reasonable benefit/risk ratio), withinthe scope of sound medical/dental judgment. The safe and effectiveamount of an agent (e.g., anti-calculus agent) may vary with theparticular condition being treated, the age and physical condition ofthe patient being treated, the severity of the condition, the durationof treatment, the nature of concurrent therapy, the specific form of thesource employed, and the particular vehicle from which the agent isapplied.

[0012] The term “non-self supporting” is used to describe a compositionthat lacks integrity and strength. In the instant case, this means thatthe composition is unable to be detached as one solid piece from theteeth even after several hours of use in the mouth. The compositioncannot be cut and formed into definite shapes, such as a sheet or cone,which maintain their initial dimensions.

[0013] The term “mucoadhesive” or “bioadhesive” as used herein refers tothe phenomenon where a natural or synthetic substance applied to a wetmucosal epithelium adheres, usually creating a new interface, to themucous layer. (CRC Critical Review in Ther Drug Carrier, Vol.5, Issue 1,p.21 (1988)). Generally, mucoadhesion can be achieved via physical orchemical processes, or both. This mechanism is described in Journal ofControlled Release, Vol.2, p257 (1982) and Journal of ControlledRelease, Vol.18 (1992) p. 249. The above references are incorporated byreference herein in their entirety.

[0014] Herein, the terms “tartar” and “calculus” are usedinterchangeably and refer to mineralized dental plaque biofilms.

[0015] The term “unit dose form” refers to physically discrete unitssuitable as unitary dosages for human subjects and other mammals, eachcontaining a predetermined quantity of active material calculated toproduce the desired therapeutic effect.

[0016] The term “viscosity” as used herein refers to kinematicviscosity, measured using the standard test method for KinematicViscosity of Transparent and Opaque Liquids (the Calculation of DynamicViscosity), ASTM D-445. As reported, viscosity is measured at 99° C.(210° F.) unless otherwise indicated. A sample is placed in a U-shaped“Cannon-Fenske” type viscometer (for transparent liquids) tube andsubmerged into a constant temperature bath. Flow is timed between twomarks on the tube and viscosity is determined by simple calculationsdependent on time and a standard factor supplied by the tubemanufacturer.

[0017] “Molecular weight”, as referred to herein, is reported as anumber average, determined using gel permeation chromatography. Thenumber average molecular weight, or arithmetic mean, is a function ofthe number of molecules in a given mass of polymer. It is represented bythe formula:$M_{n} = {\frac{\sum{N_{i}M_{i}}}{\sum N_{i}} = {\sum{n_{i}M_{i}}}}$

[0018] where N_(l), represents the number of molecules present for agiven molecular weight, M_(l) and n_(l)=N_(l)/ΣN_(l) is the numberfraction of molecular weight, M_(l).

[0019] Percentages and ratios herein are by weight of total composition,unless otherwise indicated.

[0020] Polybutene

[0021] Polybutene is a viscous copolymer of isobutylene and butenemonomers. “Polybutene”, as used herein, refers to both hydrogenated (CAS#68937-10-0) and unhydrogenated (CAS #9003-29-6) forms of the polymer.Polybutene is a viscous, colorless, non-drying, liquid polymer. Forms ofpolybutenes range from a flowable liquid to a near semi-solid state.Polybutenes are clear, odorless, chemically stable, resistant tooxidation by light and heat, non-toxic and non-hazardous.

[0022] The composition of the present invention comprises polybutene,generally of a lower molecular weight from about 300 to about 3000, inanother embodiment from about 500 to about 2200, and in anotherembodiment from about 750 to about 1500. The viscosity of the polybutenedisclosed herein, ranges from about 30 cSt (centi Stoke) measured at 38°C. to about 4,500 cSt measured at 99° C., in another embodiment fromabout 200 cSt measured at 38° C. to about 3,500 cSt measured at 99° C.and in another embodiment from about 75 cSt measured at 99° C. to about70 cSt measured at 99° C. Polybutene comprises from about 0.01% to about100%, in another embodiment from about 1% to about 100%, in yet anotherembodiment from about 50% to about 100% by weight of the composition.

[0023] The lower molecular weight polybutene of the present inventiondoes not exhibit elastomeric properties. Elastomers are amorphouspolymers that have the ability to stretch out and spring back to theiroriginal shapes. Such elastomeric polymers must have a modest amount ofcross-linking to prevent the polymeric chains from slipping over oneanother, and the chains must have an irregular shape to prevent theformation of crystalline regions within the polymeric chains. Syntheticelastomers, are described in more detail in Kirk-Othmer, Encyclopedia ofChemical Technology, Fourth Edition, Volume 8, Wiley-IntersciencePublishers (1996), pages 934-955, incorporated herein by reference inits entirety, including all references incorporated into Kirk-Othmer.The polybutene of the present invention is not cross-linked and does notexhibit rubbery or elastic behavior. When subjected to a stretching orbending force, the polybutene of the present invention does not returnto its original shape upon the removal of the force.

[0024] Lower molecular weight polybutene (Molecular Weight=300-3000),which is a flowable liquid known for its adhesive properties, isactually non-mucoadhesive. That is, the polybutene, while displayingexcellent adhesion properties on the hard surfaces of the oral cavity,will not significantly adhere to the mucosa or wet, soft tissue of themouth. Therefore, polybutene is extremely substantive when applied tothe denture, making it suitable for once daily application andtreatment. High retention of the polybutene is achieved, even whenthorough brushing has occurred. Thus, the polybutene, once applied tothe denture surface, is long lasting, and rinse resistant, which allowsfor sustained release of certain optional denture care actives.Importantly, the compositions of the present invention are notself-supporting neither before, during, nor after application to theartificial teeth.

[0025] Once applied to the denture, the polybutene has a very smooth,slick texture, perceived by the consumer as a desirable, clean feeling.The polybutene acts as a lubricant and reduces the friction normallyproduced when the tongue slides over these surfaces.

[0026] Suitable polybutenes for use herein include, but are not limitedto: Indopol L-14, Molecular Weight (“MW”)=370; Indopol L-50, MW=455;Indopol L-65, MW=435; Indopol L-100, MW=510, H-15, MW=600; H-25, MW=670;H-35, MW=725; H-40, MW=750; H-50, MW=815; H-100, MW=940; H-300, MW=1330;H-1500, MW=2145; H-1900, MW=2270; Panalane L-14E, MW=370; PanalaneH-300E, MW=1330; all trade names of BP Amoco Chemicals (Chicago, Ill.).Other suitable grades of polybutene include Parapol 450, MW=420; Parapol700, MW=700; Parapol 950, MW=950; Parapol 1300, MW=1300; and Parapol2500, MW=2700; all trade names of ExxonMobil Corporation.

[0027] Inorganic Persalt Bleaching Agent

[0028] Another essential element of the composition of the presentinvention is a bleaching agent. Typically the bleaching agent takes theform of an inorganic persalt and can be selected from any of thewell-known bleaching agents known for use in denture cleansers such asthe alkali metal and ammonium persulfates, perborates, percarbonates andperphosphates and the alkali metal and alkaline earth metal peroxides.Examples of suitable bleaching agents include potassium, ammonium,sodium and lithium persulfates and perborate mono- and tetrahydrates,sodium pyrophosphate peroxyhydrate and magnesium, calcium, strontium andzinc peroxides. Of these, however, the alkali metal persulfates,perborates and mixtures thereof are preferred for use herein. In oneembodiment the inorganic persalt bleaching agent is selected from thealkali metal perborates. Indeed, it is a feature of the invention thatthe tablet compositions herein will provide excellent antimicrobialactivity even in the absence of alkali metal persulfates.

[0029] The amount of bleaching agent in the total composition isgenerally from about 5 to about 70% preferably from about 10% to about50%. In compositions comprising a mixture of alkali metal persulfatesand perborates, the overall persulfate:perborate ratio is suitably fromabout 5:1 to about 1:5, more especially from about 2:1 to about 1:2.

[0030] Effervesence Generator

[0031] The denture cleansing compositions also comprise an effervescencegenerator, i.e. a material that, in the presence of water, releasescarbon dioxide or oxygen with effervescence. The effervescence generatorcan be selected from generators which are effective under acid, neutralor alkaline pH conditions, but preferably it consists of a combinationof a generator which is effective or most effective under acid orneutral pH conditions and a generator which is effective or mosteffective under alkaline pH conditions. Effervescence generators whichare effective under acid or neutral pH conditions include a combinationof at least one alkali metal carbonate or bicarbonate, such as sodiumbicarbonate, sodium carbonate, sodium sesquicarbonate, potassiumcarbonate, potassium bicarbonate, or mixtures thereof, in admixture withat least one non-toxic, physiologically-acceptable organic acid, such astartaric, fumaric, citric, malic, maleic, gluconic, succinic, salicylic,adipic or sulphamic acid, sodium fumarate, sodium or potassium acidphosphates, betaine hydrochloride or mixtures thereof. Of these, malicacid is preferred. Effervescence generators which are effective underalkaline pH conditions include persalts such as alkali and alkalineearth metal peroxoborates as well as perborates, persulphates,percarbonates, perphosphates, and mixtures thereof as previouslydescribed. For example, a mixture of an alkali metal perborate(anhydrous, mono-, or tetrahydrate) with a monopersulphate such asCaroat©, marketed by E I du Point de Nemours Co., which is a 2:1:1mixture of monopersulphate, potassium sulphate and potassium bisulphateand which has an active oxygen content of about 4.5%, is suitable foruse herein.

[0032] In one embodiment denture cleansing compositions in tablet form,incorporate an effervescence generator that takes the form of a solidbase material which in the presence of water releases carbon dioxide oroxygen with effervescence. Suitably, the solid base materialincorporates a (bi)carbonate/acid effervescent couple optionally incombination with a perborate/persulphate oxygen effervescence generator.The combination of generators is valuable for achieving optimumdissolution characteristics and pH conditions for achieving optimumcleaning and antimicrobial activity. The (bi)carbonate componentsgenerally comprise from about 5% to about 65%, preferably from about 25%to 55% of the total composition. The acid components generally comprisefrom about 5% to about 50%, preferably from about 10% to about 30% ofthe total composition.

[0033] Optional Ingredients

[0034] The denture cleansing compositions of the present invention canbe supplemented by other known components of such formulations. Denturecleansing compositions of the invention can be supplemented by otherusual components of such formulations, especially organic peroxyacidbleach precursors; lipophilic compounds including flavorants,physiological cooling agents, and perfumes; surfactants; chelatingagents; enzymes; dyestuffs; sweeteners; tablet binders and fillers; foamdepressants such as dimethylpolysiloxanes; foam stabilizers such as thefatty acid sugar esters; preservatives; lubricants such as talc,magnesium stearate, finely divided amorphous pyrogenic silicas, etc.;and additional therapeutic and cosmetic active agents. The free moisturecontent of the final composition is desirably less than about 1% andespecially less than about 0.5%.

[0035] Tablet Binders and Fillers

[0036] Tablet binders and fillers suitable for use herein includepolyvinyl-pyrrolidone, poly (oxyethylene) of molecular weight 20,000 to500,000, polyethyleneglycols of molecular weight of from about 1000 toabout 50,000, Carbowax having a molecular weight of from 4000 to 20,000,nonionic surfactants, fatty acids, sodium carboxymethyl cellulose,gelatin, fatty alcohols, clays, polymeric polycarboxylates, sodiumcarbonate, calcium carbonate, calcium hydroxide, magnesium oxide,magnesium hydroxide carbonate, sodium sulfate, proteins, celluloseethers, cellulose esters, polyvinyl alcohol, alginic acid esters,vegetable fatty materials of a pseudocolloidal character. Of the above,polyethyleneglycols are highly preferred, especially those havingmolecular weight of from about 1,000 to about 30,000, preferably fromabout 12,000 to about 30,000.

[0037] Organic Peroxyacid Bleach Precursors

[0038] In one embodiment the present invention further comprises anorganic peroxyacid precursor, which in general terms can be defined as acompound having a titre of at least 1.5 ml of 0.1 N sodium thiosulfatein the following peracid formation test.

[0039] A test solution is prepared by dissolving the following materialsin 1000 mls distilled water: sodium pyrophosphate (Na₄P₂O₇.10H₂O) 2.5 gSodium perborate (NaBO₂.H₂O₂.3H₂O) having 10.4% 0.615 g available oxygensodium dodecylbenzene sulphonate 0.5 g

[0040] To this solution at 60° C. an amount of activator is added suchthat for each atom of available oxygen present one molecular equivalentof activator is introduced. The mixture obtained by addition of theactivator is vigorously stirred and maintained at 60° C. After 5 minutesfrom addition, a 100 ml portion of the solution is withdrawn andimmediately pipetted onto a mixture of 250 g cracked ice and 15 mlglacial acetic acid. Potassium iodide (0.4 g) is then added and theliberated iodine is immediately titrated with 0.1 N sodium thiosulphatewith starch as indicator until the first disappearance of the bluecolour. The amount of sodium thiosulphate solution used in ml is thetitre of the bleach activator.

[0041] The organic peracid precursors are typically compounds containingone or more acyl groups, which are susceptible to perhydrolysis. Thepreferred activators are those of the N-acyl or O-acyl compound typecontaining an acyl radical R—CO wherein R is a hydrocarbon orsubstituted hydrocarbon group having preferably from about 1 to about 20carbon atoms. Examples of suitable peracid precursors include:

[0042] 1) Acyl organoamides of the formula RCONR₁R₂, where RCO iscarboxylic acyl radical, R₁ is an acyl radical and R₂ is an organicradical, as disclosed in U.S. Pat. No. 3,117,148. Examples of compoundsfalling under this group include:

[0043] a) N,N-diacetylaniline and N-acetylphthalimide;

[0044] b) N-acylhydantoins, such as N,N′-diacetyl-5,5-dimethylhydantoin;

[0045] c) Polyacylated alkylene diamines, such asN,N,N′N′-tetraacetylethylenediamine (TAED) and the correspondinghexamethylenediamine (TAHD) derivatives, as disclosed in GB-A-907,356,GB-A-907,357 and GB-A-907,358;

[0046] d) Acylated glycolurils, such as tetraacetylglycoluril, asdisclosed in GB-A-1,246,338, GB-A-1,246,339 and GB-A-1,247,429.

[0047] 2) Acylated sulphonamides, such as N-methyl-N-benzoyl-menthanesulphonamide and N-phenyl-N-acetyl menthane sulphonamide, as disclosedin GB-A-3,183,266.

[0048] 3) Carboxylic esters as disclosed in GB-A-836,988, GB-A-963,135and GB-A-1,147,871. Examples of compounds of this type include phenylacetate, sodium acetoxy benzene sulphonate, trichloroethylacetate,sorbitol hexaacetate, fructose pentaacetate, p-nitrobenzaldehydediacetate, isopropeneyl acetate, acetyl aceto hydroxamic acid, andacetyl salicylic acid. Other examples are esters of a phenol orsubstituted phenol with an alpha-chlorinated lower aliphatic carboxylicacid, such as chloroacetylphenol and chloroacetylsalicylic acid, asdisclosed in U.S. Pat. No. 3,130,165.

[0049] 4) Carboxylic esters having the general formula AcL wherein Ac isthe acyl moiety of an organic carboxylic acid comprising an optionallysubstituted, linear or branched C₆-C₂₀ alkyl or alkenyl moiety or aC₆-C₂₀ alkyl-substituted aryl moiety and L is a leaving group, theconjugate acid of which has a pKa in the range from 4 to 13, for exampleoxybenzenesulfonate or oxybenzoate. Preferred compounds of this type arethose wherein:

[0050] a) Ac is R₃-CO and R₃ is a linear or branched alkyl groupcontaining from 6 to 20, in one embodiment 6 to 12, in anotherembodiment 7 to 9 carbon atoms and wherein the longest linear alkylchain extending from and including the carbonyl carbon contains from 5to 18, in one embodiment 5 to 10 carbon atoms, R₃ optionally beingsubstituted (preferably alpha to the carbonyl moiety) by Cl, Br, OCH3 orOC₂H₅. Examples of this class of material include sodium3,5,5-trimethylhexanoyloxybenzene sulfonate, sodium3,5,5-trimethylhexanoyloxybenzoate, sodium 2-ethylhexanoyloxybenzenesulfonate, sodium nonanoyl oxybenzene sulfonate and sodiumoctanoyl oxybenezenesulfonate, the acyloxy group in each instancepreferably being p-substituted;

[0051] b) Ac has the formula R₃(AO)_(m)XA wherein R₃ is a linear orbranched alkyl or alkylaryl group containing from 6 to 20, in oneembodiment from 6 to 15 carbon atoms in the alkyl moiety, R₅ beingoptionally substituted by Cl, Br, OCH₃, or OC₂H₅, AO is oxyethylene oroxypropylene, m is from 0 to 100, X is O, NR₄ or CO—NR₄, and A is CO,CO—CO, R₆—CO, CO—R₆—CO, or CO—NR₄—R₆—CO wherein R₄ is C₁-C₄ alkyl and R₆is alkylene, alkenylene, arylene or alkarylene containing from 1 to 8carbon atoms in the alkylene or alkenylene moiety. Bleach activatorcompounds of this type include carbonic acid derivatives of the formulaR₃(AO)_(m)OCOL, succinic acid derivatives of the formula R₃OCO(CH₂)₂COL,glycollic acid derivatives of the formula R₃OCH₂COL, hydroxypropionicacid derivatives of the formula R₃OCH₂CH₂COL, oxalic acid derivatives ofthe formula R₃OCOCOL, maleic and fumaric acid derivatives of the formulaR₃OCOCH═CHCOL, acyl aminocaproic acid derivatives of the formulaR₃CONR₁(CH₂)₆COL, acyl glycine derivatives of the formula R₃CONR₁CH₂COL,and amino-6-oxocaproic acid derivatives of the formulaR₃N(R₁)CO(CH₂)₄COL. In the above, m is in one embodiment from 0 to 10,and R3 is in one embodiment C₆-C₁₂, in another embodiment C₆-C₁₀ alkylwhen m is zero and C₉-C₁₅ when m is non-zero. The leaving group L is asdefined above.

[0052] 5) Acyl-cyanurates, such as triacetyl- or tribenzoylcyanurates,as disclosed in U.S. Pat. No. 3,332,882.

[0053] 6) Optionally substituted anhydrides of benzoic or phthalic acid,for example, benzoic anhydride, m-chlorobenzoic anhydride and phthalicanhydride.

[0054] In one embodiment, organic peracid precursors are of types 1(c)and 4(a).

[0055] Where present, the level of peroxyacid bleach precursor, byweight of the total composition, is from about 0.1% to about 10%, in oneembodiment from about 0.5% to about 5% and is generally added in theform of a bleach precursor agglomerate.

[0056] The bleach precursor agglomerates preferred for use hereingenerally comprise a binder or agglomerating agent, selected from thosetablet binders or fillers described above, in a level of from about 5%to about 40%, in one embodiment from about 10% to about 30% by weightthereof.

[0057] Preferred from the viewpoint of optimum dissolution and pHcharacteristics are bleach precursor agglomerates which comprise fromabout 10% to about 75%, in one embodiment from about 20% to about 60% byweight thereof of peroxyacid bleach precursor, from about 5% to about60%, in one embodiment from about 5% to about 50%, in another embodimentfrom about 10% to about 40% of a (bi) carbonate/acid effervescentcouple, from about 0% to about 20% of a peroxoboroate, and from about 5%to about 40%, in one embodiment from about 10% to about 30% of anagglomerating agent. The final bleach precursor granules desirably havean average particle size of from about 500 to about 1500, in oneembodiment from about 500 to about 1,000 um, this being valuable fromthe viewpoint of optimum dissolution performance and aesthetics. Thelevel of bleach precursor agglomerates, moreover, is from about 1% toabout 20%, in one embodiment from about 5% to about 15% by weight ofcomposition.

[0058] Surfactants

[0059] Another optional ingredient of the denture cleansing compositionsof the invention is a surfactant. The surfactant can be selected fromthe many available that are compatible with the other ingredients of thedenture cleanser, both in the dry state and in solution. Such materialsare believed to improve the effectiveness of the other ingredients ofthe composition by aiding their penetration into the interdentalsurfaces. Also, these materials aid in the removal of food debrisattached to the teeth. Between 0.1% and 5%, by weight of the drycomposition of a dry powder or granular anionic surface active agent,such as sodium lauryl sulfate, sodium N-lauroylsarcosinate, sodiumlauryl sulfoacetate or dioctyl sodium sulfosuccinate or ricinoleylsodium sulfosuccinate, may, for example, be included in the compositionand in one embodiment the surfactant comprises between 0.5% and 4% ofthe composition.

[0060] Suitable cationic, non-ionic and ampholytic surface active agentsinclude, for example, quaternary ammonium compounds such ascetyltrimethyl-ammonium bromide, condensation products of alkyleneoxides such as ethylene or propylene oxide with fatty alcohols, phenols,fatty amines or fatty acid alkanolamides, the fatty acid alkanolamidesthemselves, esters of long-chained (C₈-C₂₂) fatty acids withpolyalcohols or sugars, for example glycerylmonostearate or saccharosemonolaurate or sorbitolpolyoxyethylenemono-or di-stearate, betaines,sulphobetaines or long-chain alkylaminocarboxylic acids.

[0061] In one embodiment the surfactant is a silicone surfactant havingthe general formula (I):

[0062] wherein X is selected from hydrogen, alkyl, alkoxy and acylgroups having from about 1 to about 16 carbon atoms, Y is CH₃, q is 0, nis from about 1 to about 100, m is from about 1 to about 40, themolecular weight of the residue (C₂H₄O—)_(x)(C₃H₆O—)_(y)X is from about50 to about 2000, and x and y are such that the weight ratio ofoxyethylene:oxypropylene is from about 100:0 to about 0:100.

[0063] The silicone surfactant, a dimethicone copolyol, assists indispersing the polybutene in an aqueous media whilst still allowing thepolybutene to deposit onto denture surfaces. In one embodiment, thesilicone surfactant is selected from dimethicone copolyols having a HLBvalue of greater than 14 and mixtures thereof. Highly preferred areend-capped (X is alkyl, more particularly methyl) dimethicone copolyols,especially where the pendant side chain is all oxyethylene (y is 0),such as that marketed under the Trade Name Silwet L7600. The siliconesurfactant is generally present in a level of from about 0.01% to about25%, in one embodiment from about 0.3% to about 10%, in anotherembodiment from about 0.5% to about 5%, by weight. It will beappreciated that the precise amount will depend on the amount of thepolybutene used.

[0064] Lipophilic Compounds

[0065] The denture cleanser compositions of the present invention mayalso include a lipophilic compound. In general terms, lipophiliccompounds suitable for use herein are oil-like materials which aresoluble or solubilisable in the polybutene, typically at a level of atleast about 1%, in one embodiment at least about 5%, by weight at 25° C.Preferred lipophilic compounds are selected from flavorants,physiological cooling agents, perfumes and antimicrobial compounds. Thepolybutene acts to enhance the substantivity of the lipophilic compoundto teeth and/or dentures, thereby providing enhanced and/or sustainedflavor impact and antimicrobial efficacy.

[0066] Lipophilic flavorants suitable for use herein comprise one ormore flavor components selected from wintergreen oil, oregano oil, bayleaf oil, peppermint oil, spearmint oil, clove oil, sage oil, sassafrasoil, lemon oil, orange oil, anise oil, benzaldehyde, bitter almond oil,camphor, cedar leaf oil, marjoram oil, citronella oil, lavendar oil,mustard oil, pine oil, pine needle oil, rosemary oil, thyme oil,cinnamon leaf oil, and mixtures thereof.

[0067] Lipophilic antimicrobial compounds suitable for use hereininclude thymol, menthol, triclosan, 4-hexylresorcinol, phenol,eucalyptol, benzoic acid, benzoyl peroxide, butyl paraben, methylparaben, propyl paraben, salicylamides, and mixtures thereof.

[0068] The carboxamides found most useful are those described in U.S.Pat. No. 4,136,163, Jan. 23, 1979 to Wason et al., and U.S. Pat. No.4,230,688, Oct. 28, 1980 to Rawsell et al.

[0069] Physiological cooling agents suitable for use herein includecarboxamides, menthane esters, menthane ethers, and mixtures thereof.Suitable menthane ethers for use herein are selected from those with theformula:

[0070] where R₅ is an optionally hydroxy substituted aliphatic radicalcontaining up to 25 carbon atoms, preferably up to 5 carbon atoms, andwhere X is hydrogen or hydroxy, such as those commercially availableunder the trade name Takasago, from Takasago International Corporation.A particularly preferred cooling agent for use in the compositions ofthe present invention is Takasago 10 [3-1-menthoxy propan-1,2-diol(MPD)]. MPD is a monoglycerin derivative of 1-menthol and has excellentcooling activity.

[0071] The level of lipophilic compound in the compositions of theinvention is generally in the range from about 0.001% to about 10%, inone embodiment from about 0.05% to about 5%, in another embodiment fromabout 0.1% to about 3%, by weight.

[0072] Chelating Agents

[0073] Chelating agents beneficially aid cleaning and bleach stabilityby keeping metal ions, such as calcium, magnesium, and heavy metalcations in solution. Examples of suitable chelating agents includesodium tripolyphosphate, sodium acid pyrophosphate, tetrasodiumpyrophosphate, aminopoly-carboxylates such as nitrilotriacetic acid andethylenediamine tetracetic acid and salts thereof, and polyphosphonatesand aminopolyphosphonates such as hydroxyethanediphosphonic acid,ethylenediamine tetramethylene-phosphonic acid,diethylenetriaminepentamethylenephosphonic acid and salts thereof. Thechelating agent selected is not critical except that it must becompatible with the other ingredients of the denture cleanser when inthe dry state and in aqueous solution. Advantageously, the chelatingagent comprises between 0.01% and 60%, by weight of the composition, inone embodiment between 0.5% and 30%. Phosphonic acid chelating agents,however, comprise from about 0.001% to about 1%, in one embodiment fromabout 0.01% to about 0.5%, by weight of composition.

[0074] Enzymes

[0075] Enzymes suitable for use herein are exemplified by proteases,alkalases, amylases, lipases, dextranases, mutanases, glucanases etc.

[0076] Therapeutic and Cosmetic Agents

[0077] The denture cleanser compositions of the present invention mayfurther comprise one or more therapeutic or cosmetic active agentsselected from the group consisting of anti-calculus agents, fluorideions sources, stannous ion sources, additional whitening agents,anti-microbial, anti-plaque agents, anti-inflammatory agents, nutrients,antioxidants, anti-viral agents, anti-fungal agents, analgesic andanesthetic agents, H-2 antagonists, components other than polybutenewhich impart a clean feel to the dentures, pigments, dyes, lakes andcolorants, and mixtures thereof. In one embodiment the therapeutic andcosmetic active agents are selected from the group consisting oftriclosan, baking soda, sodium fluoride, potassium nitrate, sodiumnitrate, nystatin, grapefruit seed extract, stannous fluoride, tetrasodium pyrophosphate, mono fluoro phosphate, Opatint D&C Red 27,polyphosphates, such as sodium hexametaphosphate, and cetylpyridiumchloride.

[0078] The denture cleansing compositions of the invention can be inpaste, tablet, granular or powder form, although tablet-formcompositions are highly preferred herein. Compositions in tablet formcan be single or multiple layered tablets.

[0079] The following Examples further describe and demonstrate thepreferred embodiments within the scope of the present invention.

EXAMPLES I TO V

[0080] The following are representative denture cleansing tabletsaccording to the invention. The percentages are by weight of the totaltablet. The tablets are made by compressing a mixture of the granulatedcomponents in a punch and dye tabletting press at a pressure of about10⁵ kPa. I II III IV V Malic Acid 12 10 12 — 14 Citric Acid — 10 — 12 —Sodium Carbonate 10 8 8 6 10 Sulphamic Acid 5 — — 3 3 PEG 20,000 — 3 5 45 PVP 40,000 5 3 — — — Sodium Bicarbonate 21 23.2 23.9 13.9 20 SodiumPerborate Monohydrate 15 12 13 27 14 Potassium Monopersulphate 14.4 1611 — 13.5 Pyrogenic Silica 0 0.3 0.1 0.1 — Talc 2 — — — — EDTA — — 1 — 3EDTMP¹ 1 — — 1 — Flavor⁴ 2 1 2 1 2 Polybutene 0.6 1.5 5 8 0.5 SilwetL7600⁵ 3 4 — 12 5 Silwet L7230⁶ — — 9 — — Bleach Precursor AgglomerateTAED² 2 — 4 5 2.5 TMHOS³ 2 3 — — — Sulphamic Acid 2 2 2 2 3.5 SodiumBicarbonate 0.5 0.2 0.2 0.5 2 PEG 6000 2.5 2 2.4 2.5 1.5 Dye — 0.8 1.4 20.5 Total 100 100 100 100 100

[0081] In Examples I to V above, the overall tablet weight is 3 g;diameter 25 mm. The polybutene of Examples I to V is Indopol H-40,MW=750, trade name of BP Amoco Chemicals (Chicago, Ill.). The denturecleansing tablets of Examples I to V display improved antiplaque,cleansing and anti-bacterial activity together with excellent cohesionand other physical and in-use performance characteristics.

EXAMPLES VI TO VIII

[0082] The following are representative denture cleansing pastesaccording to the invention. The percentages are by weight of totalcomposition. VI VII VIII Calcium Carbonate 20 25 15 Glycerine 10 12 8Sodium CMC 3.5 3 4 Titanium Dioxide 0.7 0.5 0.6 Methyl/Propyl Parabens0.1 0.1 0.1 Sodium Saccharin 0.3 0.4 0.2 Flavor⁴ 1 1 2 Polybutene 1 1.50.3 Silwet L7600⁵ 3 2.5 2 Triclosan — 0.5 — Water To 100%

[0083] The polybutene of Examples VI to VIII is Indopol H-300, MW=1330,trade name of BP Amoco Chemicals (Chicago, Ill.). The denture cleansingpastes of Examples VI to VIII display improved antiplaque, flavor impactand anti-bacterial activity together with excellent cleansingcharacteristics.

[0084] The dentures or artificial teeth that are treated with thedenture cleanser compositions described above should be exposed to thedenture cleanser composition for a period of about 10 seconds to severalhours, as in overnight treatment.

[0085] It is understood that the examples and embodiments describedherein are for illustrative purposes only and that various modificationsor changes in light thereof will be suggested to one of skill in the artwithout departing from the scope of the present invention.

What is claimed:
 1. A denture cleanser composition comprising a.) polybutene with a molecular weight of about 300 to about 3000; b.) an inorganic persalt bleaching agent; and c.) an effervescence generator
 2. The denture cleanser composition of claim 1 wherein the inorganic persalt bleaching agent comprises one or more bleaching agents selected from the group consisting of alkali metal persulfates, alkali metal perborates and mixtures thereof.
 3. The denture cleansing composition of claim 1 wherein the effervescence generator comprises a (bi)carbonate/acid effervescent couple.
 4. The denture cleanser composition of claim 1 further comprising a peroxyacid bleach precursor.
 5. The denture cleanser composition of claim 4 wherein the organic peroxyacid precursor is selected from the group consisting of acylated polyalkyldiamines and carboxylic esters having the general formula AcL wherein Ac is the acyl moiety or an organic carboxylic acid comprising an optionally substituted, linear or branched C6-C20 alkyl or alkenyl moiety or a C6-C20 alkyl-substituted aryl moiety and L is a leaving group, the conjugate acid of which has a pKa in the range of 4 to
 13. 6. The denture cleanser composition of claim 5 wherein the organic peroxyacid precursor is tetraacetylethylenediamine.
 7. The denture cleanser composition of claim 1 further comprising a dental abrasive.
 8. The denture cleanser composition of claim 7 wherein the dental abrasive is at a level from about 10% to about 70% by weight and is selected from the group consisting of silica, alumina, aluminosilicates, magnesium and zirconium silicates, calcium ortho-, pyro- meta- and polyphosphates, calcium and magnesium carbonates, insoluble metaphosphates and thermosetting polymerized resins.
 9. The denture cleanser composition according to claim 1 further comprising a binder.
 10. The denture cleanser composition according to claim 9 wherein the binder is present at a level of from about 0.1% to about 10%, by weight.
 11. The denture cleanser composition according to claim 1 further comprising a chelating agent.
 12. The denture cleanser composition according to claim 1 further comprising a lipophilic compound.
 13. The denture cleanser composition of claim 12 wherein the lipophilic compound comprises a flavorant comprising one or more flavor components selected from the group consisting of wintergreen oil, oregano oil, bay leaf oil, peppermint oil, spearmint oil, clove oil, sage oil, sassafras oil, lemon oil, orange oil, anise oil, benzaldehyde, bitter almond oil, camphor, cedar leaf oil, marjoram oil, citronella oil, lavender oil, mustard oil, pine oil, pine needle oil, rosemary oil, thyme oil, cinnamon leaf oil, and mixtures thereof.
 14. The denture cleanser composition of claim 13 wherein the lipophilic compound comprises antimicrobial compound selected from thymol, menthol, triclosan, 4-hexylresorcinol, phenol, methyl paraben, eucalyptol, benzoic acid, benzoyl peroxide, butyl paraben, methyl paraben, propyl paraben, salicylamides, and mixtures thereof.
 15. The denture cleanser composition of claim 1 further comprising a surfactant.
 16. The denture cleanser composition of claim 15 wherein the surfactant is a silicone surfactant selected from dimethicone copolyols, of the general formula (I)

wherein X is selected from hydrogen, alkyl, alkoxy and acyl groups having from about 1 to about 16 carbon atoms, Y is CH₃, q is 0, n is from about 1 to about 100, m is from about 1 to about 40, the molecular weight of the residue (C₂H₄O—)_(x)(C₃H₆O—)_(y)X is from about 50 to about 2000, and x and y are such that the weight ratio of oxyethylene:oxypropylene is from about 100:0 to about 0:100.
 17. The denture cleanser composition of claim 16 wherein the surfactant is a dimethicone copolyol, of the general formula (I) wherein the end-capping group X is methyl and y is 0, and mixtures thereof.
 18. The denture cleanser composition of claim 1, wherein the polybutene has a molecular weight of from about 500 to about
 2200. 19. The denture cleanser composition of claim 1, wherein the polybutene has a molecular weight of from about 750 to about
 1500. 20. The denture cleanser of claim 1 further comprising one or more denture care active agents selected from the croup consisting of anti-calculus agents, fluoride ions sources, stannous ion sources, additional whitening agents, anti-microbial and anti-plaque agents, anti-inflammatory agents, nutrients, antioxidants, anti-viral agents, anti-fungal agents, analgesic and anesthetic agents, H-2 antagonists, components other than polybutene which impart a clean feel to the dentures, pigments and colorants, and mixtures thereof.
 21. The denture cleanser of claim 20 wherein the denture care active is selected from the group consisting of triclosan, baking soda, sodium fluoride, potassium nitrate, sodium nitrate, nystatin, grapefruit seed extract, stannous fluoride, tetra sodium pyrophosphate, mono fluoro phosphate, Opatint D&C Red 27, polyphosphates, and cetylpyridium chloride.
 22. The denture cleanser of claim 20 wherein the polyphosphate is sodium hexametaphosphate.
 23. The denture cleanser composition of claim 20 wherein the fluoride ion source, if present, is in an amount sufficient to provide from about 50 ppm to about 3500 ppm of fluoride ions. 